The Recall Desk

Manufacturer

Advanced Accelerator Applications USA, Inc.

4 recalls in our database name Advanced Accelerator Applications USA, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2024-10-09

Of the 4 recalls from Advanced Accelerator Applications USA, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–4 of 4

  • HighFDA (Drugs)·D-0007-2025·2024-10-09

    Pluvicto Radiopharmaceutical Drug Recalled Due to Manufacturing Quality Deviations

    Advanced Accelerator Applications is recalling 99 doses of Pluvicto (lutetium LU-177 injection) due to manufacturing quality deviations. The affected lots were distributed to six states.

    Product
    Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufacturer Advanced Accelerator Applications, 57 E. Willow Street, NJ 07041, Millburn USA. NDC 69488-0010-61
    Category
    Drug
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-1085-2023·2023-08-23

    PLUVICTO Injection Recalled for Incorrect Lot and Expiration Date Labels

    PLUVICTO (lutetium Lu 177 vipivotide tetraxetan) injection vials were labeled with incorrect lot numbers and expiration dates. The manufacturer is recalling affected lots distributed nationwide.

    Product
    PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9.2 mL Single-dose vial, Manufacturer: Advanced Accelerator Appllications USA, Inc., 57 E. Willow Street NJ 07041, Milburn, USA, NDC 69488-010-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0747-2022·2022-04-13

    NETSPOT prescription drug kit recalled for subpotency in vial 1

    Advanced Accelerator Applications recalls approximately 14,089 NETSPOT kits distributed nationwide due to subpotency detected during stability studies. The affected lots contain insufficient active ingredient concentration.

    Product
    NETSPOT — NETSPOT (68GA-DOTATATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0799-2020·2020-01-29

    FDA Recalls NETSPOT Kits Due to Defective Aluminum Cap Crimp

    Advanced Accelerator Applications USA, Inc. is recalling NETSPOT kits because the dilution buffer vial has a loose aluminum cap crimp.

    Product
    NETSPOT — NETSPOT (68GA-DOTATATE)
    Category
    Drug
    Distribution
    Distributed nationwide